Identity
- Trade Name
- Advanced Gynecological Applicator FDA UDI
- Generic Name
- Bronchial brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Intrauterine Tube 40mm 30° FDA UDI
- Model / Reference
- 126015-01 FDA UDI
- Description
- Intrauterine Tube 40mm 30° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08717213055025 FDA UDI
- 510(k) Number
- K161688 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- GMDN Term
- Bronchial brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Bronchial brachytherapy system applicator, remote-afterloading
Advanced Gynecological Applicator by Nucletron B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bronchial brachytherapy system applicator, remote-afterloading.
- Scaled pull rod, VariSource only — Varian Medical Systems Deutschland GmbH · Class II
- Scaled pull rod, GammaMed only — Varian Medical Systems Deutschland GmbH · Class II
- 4.7 Fr. plastic-tipped catheter, 150 cm — Varian Medical Systems Deutschland GmbH · Class II
- Centering Intraluminal Applicator Set — Varian Medical Systems Deutschland GmbH · Class II
- Guide tube for centering catheter — Varian Medical Systems Deutschland GmbH · Class II
- 4.7 Fr. plastic-tipped catheter, 100 cm — Varian Medical Systems Deutschland GmbH · Class II
- Centering Intraluminal Applicator Set — Varian Medical Systems Deutschland GmbH · Class II
- Lock screw for centering catheter, pack of 3 — Varian Medical Systems Deutschland GmbH · Class II
Cleared under the same submission
K161688 also covers:
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
- Advanced Gynecological Applicator — Nucletron B.V.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nucletron B.V.
Sources (1)
- FDA UDI 4f596581-090d-4d4d-8535-ec04385a15e8 35 fields · synced May 30, 2026